Our goal is complete customer satisfaction. Communication is an important aspect of meeting that goal. Our sales staff and our customer service department work together to make sure that your requirements are known and consistently fulfilled.
Below are some of our most frequently asked questions, if you would like further information please feel free to send us an email via our contact us page or call us at (714) 672-1090.
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We maintain the following certificates as part of our quality system. Visit our certifications page to view or download a copy of each certificate.
- FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
- State of California: Device Manufacturing License
- State of California: Drug Manufacturing License>
- State of California: Drug Wholesaler License
- International Standard ISO 13485:2003
- International Standard I.S. EN ISO 13485:2012
- International Standard ISO 17665:2006 Moist Heat Sterilization
- ISTA Certified Package Testing Laboratory
- Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices
Through our six divisions, LSO is capable in supporting activities from development through production. Service divisions include:
- Medical Device Manufacturing
- Medical Package Testing
- Sterilization Validation Services
- Fulfillment & Distribution Services
- Offshore Manufacturing
- LSO Incubator Services
LSO is located in Brea, California, about 30 minutes from the nearest Medical Device hub in Irvine. We are also in close proximity to LAX Airport and Long Beach Port. Our location allows for greater monitoring and on-hands involvement with our Offshore Manufacturing partner, conveniently located just south of the border in Tijuana, Mexico. Our customers include both domestic and international clientele.
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LSO is a 56,000 square foot facility consisting of 10,000 sq. ft. of Class 10,000, 500 sq ft of Class 1000 and 180 sq ft of Class 100 clean rooms, 8,000 sq. ft. of office space and the remainder dedicated to storage and warehousing.Learn more about our facility
LSO can assist early stage companies that may not be registered with the FDA as a manufacturer or any Medical Device company without their own facilities, the opportunity to use LSO Class 10,000 clean rooms. We provide an option to rent clean room space on a daily basis to build prototypes or small lots and use equipment and engineering staff to assist you in the early stages of product development.
In addition to the company website, LSO and industry news is regularly updated on to our Facebook page and Twitter account. You can also follow us on the Company Blog where we delve deeper into industry events and trends. Finally you can find us on YouTube through our corporate channel. In the near future we also hope to bring to you an industry newsletter.
LSO has been in business for over fifteen and has served approximately 400 companies. There are several clinical spaces and market segments that we have served. Please see the list below:
- Cardiac Rhythm Systems
- Dental Implants
- Minimally Invasive Devices
- Specialty Kits
LSO works with a variety of different size and types of medical device companies. We are most appealing to companies looking for the following advantages:
- Turnkey Solutions
- Cost & Efficiency Savings
- Reduced Overhead
- Ability and Flexibility to Focus on your Core Activities
- Quicker Time to Market
- Access to Industry Expertise
- Staffing Flexibility
- Risk-Sharing / Management
LSO operates under a Non-Disclosure Agreement with all companies, prior to beginning discussions. In addition, when these companies become customers, they are assigned a three letter code, to protect their privacy. All internal discussions, documentation and warehousing facilities reflect only the companies' letter code, to insure privacy and confidentiality.
The inquirer immediately receives a return email acknowledging receipt of their inquiry. In most cases, the individual is contacted with an hour or two for initial discussions and questioning.
LSO is extremely sensitive to the customer's needs and will develop a quote as rapidly as necessary to fulfill necessary timelines.
Once an NDA is in place, a phone conference is generally scheduled to begin discussions.